Stability studies
Stability programmes designed against ICH guidance and the climatic zone of the target registration market, covering Zones II, IVa and IVb for GCC, Middle East and tropical submissions.
Long-term
ICH-compliant chambers running real-time stability under the climatic zone of the registration market. Zones II, IVa and IVb covered for GCC, Middle East and tropical submissions.
Accelerated
40 °C / 75% RH conditions to support shelf-life prediction and out-of-specification investigations.
Intermediate
30 °C / 65% RH (Zone II) or 30 °C / 75% RH (Zone IVb) where indicated for the dosage form and target market.
In-use stability
Studies for multi-dose products, reconstituted suspensions and opened-bottle protocols.
Photo-stability
ICH Q1B option 2 testing for photo-sensitive APIs and finished products.
Transport simulation
Cycling and stress profiles modelled against the realistic supply chain.
Stability protocol governance
Each protocol is reviewed against ICH Q1A(R2), ICH Q1E and the target market guidance before chambers are charged. Sample pull schedules, analytical methods and acceptance criteria are locked at study start; deviations and out-of-trend results are managed under the quality system.
Need a stability programme designed?
From single-batch feasibility to full registration packages, we scope and price stability studies against the market and dossier in scope.